Position Overview:

As part of our continuous growth, we are seeking a highly skilled and experienced Industrialization Lead to join our dynamic team. In this role, you will be the one driving the manufacturing strategies definition, working with the R&D team to ensure efficient design transfer to operation teams, and ensuring the efficient setup of manufacturing capabilities. You will identify regulatory and good manufacturing practice requirements and oversee all industrialisation processes throughout development and manufacturing, contributing to the deliverability of the Lakhesys Benchtop Cell Factory™.

Main Responsibilities:

• Analyze existing documentation and practices from our manufacturing partner to understand and optimize current production methods of the Lakhesys™

• Develop and implement internal equipment manufacturing workflows, procedures, and quality controls

• Support the qualification of the new equipment, tools, and fixtures for in-house manufacturing of single-use systems

• In collaboration with the COO, draw and execute equipment manufacturing strategy

• Collaborate with R&D and Product Development to ensure that Design for Manufacturing principles are applied

• Work with Quality Assurance to ensure compliance with ISO 13485 and relevant regulatory standards

• Identify and implement continuous improvement opportunities to reduce cost, lead time, and risk

• Support pilot production, prototyping, and early-stage industrialization

• Could in the future, support the COO in the initial setup of a early supply chain organization by providing expertise in procurement, logistics, ERP systems, and master data management.

Qualifications:

Technical skills:

• Master’s degree in Engineering, Industrial Engineering, or related field

• 10+ years of experience leading the industrialization of early-stage prototypes through full product launch, ideally within complex mechatronic systems or comparable technologies

• Demonstrated experience with technology transfer and process industrialization dealing and negotiating with different suppliers

• Knowledge in GMP, ISO 13485, or other highly regulated environments

• Fluent in English (French is a plus)

Interpersonal and Leadership Skills:

• Hands-on, solution-oriented, and autonomous

• Analytical and strategic thinking

• Strong understanding in Product Development towards Product Launch

Entretien avec Manon - HRBP

Entretien Fit avec Didier et Manon

Entretiens techniques et rencontres sur site avec l’équipe